MAUDE Adverse Event Report: SMITH & NEPHEW INC., ENDOSCOPY DIVISION TRUCLEAR ULTRA PLUS TISSUE REMOVAL DEVICE; TISSUE REMOVAL DEVICES

Model Number 72203012

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

According to the reporter, during a gynecology procedure the blade bent.To correct the condition, the user opened a new blade.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The event report alleges the product was not used in a surgical procedure.The visual inspection of the returned product noted the tip of the device was bent.No functional testing was performed.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Damage to the tip can occur if the device is incorrectly inserted into the hysteroscope.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

Event Description

There was no patient involvement.There was no patient injury.No medical intervention was required.There was no patient death.There were no labeling or packaging issues.

• Brand Name: TRUCLEAR ULTRA PLUS TISSUE REMOVAL DEVICE
• Type of Device: TISSUE REMOVAL DEVICES
• Manufacturer (Section D): SMITH & NEPHEW INC., ENDOSCOPY DIVISION; 75 s. meridian ave.; oklahoma city OK 73107
• Manufacturer (Section G): SMITH & NEPHEW INC., ENDOSCOPY DIVISION; 75 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven
• MDR Report Key: 6136037
• MDR Text Key: 61145106
• Report Number: 1643264-2016-20004
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72203012
• Device Catalogue Number: 72203012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/04/2016
• Initial Date FDA Received: 11/30/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/31/2017; 05/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1